The influence of low- intensity laser irradiation versus hyperbaric oxygen therapy on transcutaneous oxygen tension in chronic diabetic foot ulcers: a controlled randomized trial

Natrox™ topical oxygen therapy (TOT) ( Inotec AMD Ltd, Hertfordshire, UK) employs a small battery-powered “oxygen generator” to concentrate atmospheric oxygen and feeds pure, moist, oxygen through a fine, soft tube to a dressing-like “oxygen distribution system”, which is placed over the wound and is held in place by a conventional dressing. The aim was to determine the effectiveness of Natrox™ for non-healing diabetic foot ulcers (DFU) over a 3-month period.Longitudinal, single-arm, open prospective registry study using 12 weeks of TOT using a 4 week run-in period. 20 patients recruited to OTONAL had chronic DFU greater than 3 months duration or minor amputation sites with less than 50% healing in 4 weeks.There were 13 (65%) males and the mean age was 65.7 (±11.6) years. The mean glycated haemoglobin (HbA1c) was 6.9 (±1.3) mmol mol−1 and mean wound duration before TOT was 114 (±79.1) days. 18/20 (90.0%) patients had concomitant lower limb revascularization angioplasty for chronic limb threatening ischaemia. The mean size of the foot ulcer at baseline was 11.3 ± 14.8 cm2 and mean transcutaneous oxygen measurement value was 34.1 (±19.6) mm Hg. Wound closure of >75% was observed in 14/20 (70.0%) patients. There was a 91.3% (±14.9%) wound area reduction by 3 months (P = .001) and mean time for 100% closure was 77.6 ± 32.5 days. Mean pain scores reduced from 2.4 (±1.8) at baseline to .5 (±1.0) at 3 months (P = .008). All patients were very satisfied using the ambulatory device. Use of TOT in chronic diabetic foot wounds stimulates a healing state, underpinning the concept that oxygen plays a central role in wound healing. Our results are more compelling if you consider they started with relatively large-sized DFUs and majority of patients were frail with underlying peripheral artery disease. (NCT03863054)

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Reply: Hyperbaric Oxygen Therapy in Management of Diabetic Foot Ulcers: Indocyanine Green Angiography May Be Used as a Biomarker to Analyze Perfusion and Predict Response to Treatment

Plastic & Reconstructive Surgery ◽

10.1097/prs.0000000000008759 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Babak Hajhosseini ◽

Geoffrey C. Gurtner

Keyword(s):

Indocyanine Green ◽

Hyperbaric Oxygen ◽

Diabetic Foot ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Indocyanine Green Angiography ◽

Response To Treatment ◽

Foot Ulcers ◽

Diabetic Foot Ulcers

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Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

10.21203/rs.2.16819/v1 ◽

2019 ◽

Author(s):

Jocefabia Reika Alves Lopes ◽

Mariza D’Agostino Dias ◽

João Antonio Correa ◽

Maria Alice Bragagnolo Batalha ◽

Luanda Karla Dantas Guerra

Keyword(s):

Hyperbaric Oxygen ◽

Diabetic Foot ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Standard Treatment ◽

Foot Ulcers ◽

Control Group ◽

Diabetic Patients ◽

Diabetic Foot Ulcers

Abstract Background: Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers and reducing the number of amputations in these patients.Methods : The study will be conducted in the city of Imperatriz, Maranhão from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grade 2, 3, and 4, persisting for more than one month). The outpatient follow-up for diabetic foot patients will be done at the SUS (Unified Health System), with a sample size of 120 patients (60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics, and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after six months. The patients of the control group will also be evaluated at equivalent periods. The progression of the wounds and specific treatment, such as appropriate bandage, antibiotic therapy, or need of some surgical intervention will be evaluated on a weekly basis. The SF-36 quality of life questionnaire will be filled upon admission and after three months of follow-up in both groups. Upon admission, the patients of both groups will undergo arterial Doppler ultrasound, and laboratory tests–complete blood count, erythrocyte sedimentation rate, C-reactive protein, creatinine, fasting blood glucose, and glycosylated haemoglobin.Discussion : Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers.

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